Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00025259 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : March 7, 2017
Last Update Posted : April 12, 2017
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief Summary:
This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma Childhood Mixed Cellularity Classical Hodgkin Lymphoma Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma Childhood Nodular Sclerosis Classical Hodgkin Lymphoma Stage I Childhood Hodgkin Lymphoma Stage II Childhood Hodgkin Lymphoma Stage III Childhood Hodgkin Lymphoma Stage IV Childhood Hodgkin Lymphoma | Biological: Bleomycin Sulfate Drug: Cisplatin Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Doxorubicin Hydrochloride Drug: Etoposide Biological: Filgrastim Radiation: Involved-Field Radiation Therapy Drug: Prednisone Drug: Vincristine Sulfate Liposome | Phase 3 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1734 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease |
| Study Start Date : | September 2002 |
| Actual Primary Completion Date : | August 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hodgkin Disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (Patients off-therapy before callback-Induction only)
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
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Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
|
Experimental: Arm II (RER with CR [ABVE-PC, IFRT])
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
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Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Radiation: Involved-Field Radiation Therapy Undergo IFRT
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
|
Experimental: Arm III (RER with CR [ABVE-PC])
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.
|
Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
|
Experimental: Arm IV (RER with less than CR [ABVE-PC, IFRT])
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.
|
Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Radiation: Involved-Field Radiation Therapy Undergo IFRT
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
|
Experimental: Arm V (RER with PD)
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.
|
Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
|
Experimental: Arm VI (SER [DECA, ABVE-PC, IFRT])
Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, and cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 and 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
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Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cisplatin Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Cytarabine Given IV
Other Names:
Drug: Dexamethasone Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Radiation: Involved-Field Radiation Therapy Undergo IFRT
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
|
Experimental: Arm VII (SER [ABVE-PC, IFRT])
Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
|
Biological: Bleomycin Sulfate
Given IV or SC
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given SC
Other Names:
Radiation: Involved-Field Radiation Therapy Undergo IFRT
Other Names:
Drug: Prednisone Given orally
Other Names:
Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
Primary Outcome Measures :
- Event-free Survival [ Time Frame: 5 years ]Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.
Secondary Outcome Measures :
- Disease Response Assessed by Modified RECIST Criteria [ Time Frame: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days. ]Number of participants with complete response and very good partial response at the end of protocol therapy.
- Grade 3 or 4 Non-hematologic Toxicity [ Time Frame: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days. ]Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
- Overall Survival [ Time Frame: 5 years ]Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.
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| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines:
- All Stage IB regardless of bulk disease
- All Stage IIB regardless of bulk disease
- Stage IA only with bulk disease
- Stage IIA only with bulk disease
- All Stage IAE, IIAE regardless of bulk disease
- All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease
- All Stage IVA, IVAE regardless of bulk disease
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May not be staged by laparotomy alone
- Surgically staged patients must also have presurgical staging
- Bilirubin no greater than 1.5 times normal
- SGOT or SGPT less than 2.5 times normal
- Creatinine no greater than 1.5 times normal
- Creatinine clearance greater than 40 mL/min
- Radioisotope glomerular filtration rate greater than 70 mL/min
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- No pathologic prolongation of QTc interval on 12-lead electrocardiogram
- FEV_1/FVC greater than 60% by pulmonary function test
- Pulse oximetry greater than 94%
- No evidence of dyspnea at rest
- No exercise intolerance
- Adequate venous access
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy
- At least 1 month since prior corticosteroids except prednisone for respiratory distress
- No prior radiotherapy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025259
Locations
Show 175 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Debra Friedman | Children's Oncology Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00025259 |
| Other Study ID Numbers: |
AHOD0031 NCI-2011-02069 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000068943 COG-AHOD0031 AHOD0031 ( Other Identifier: Childrens Oncology Group ) AHOD0031 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | March 7, 2017 |
| Last Update Posted: | April 12, 2017 |
| Last Verified: | May 2016 |
Additional relevant MeSH terms:
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisone Dexamethasone acetate Cortisone Cyclophosphamide Cisplatin |
Doxorubicin Liposomal doxorubicin Etoposide Vincristine Etoposide phosphate Bleomycin Podophyllotoxin Lenograstim BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |